Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke
12 aprile 2021 aggiornato da: Taipei Medical University
Transcranial electrical stimulation (tCES) is contemporarily important issues in the advanced rehabilitation medicine.
tCES can selectively change the excitability of regional cortex with non-invansive and safety properties.
Therefore, the investigators aim to develop a set of tCES system with special waveforms for using in clinical rehabilitation of upper extremities.
This developed tCES system is smaller than all commercial available products, which could be conveniently and portably wore on head for clinical rehabilitation.
In addition, the present tCES system with special waveforms developing by the investigators is much more efficient on improving neuroplasticity than the traditional transcranial direct current stimulation (tDCS) in rats.
The investigators hope the tCES system combined with the rehabilitation of body extremities will become a routine treatment for stroke patients at hospitals or residential rehabilitation in the future.
Panoramica dello studio
Descrizione dettagliata
Transcranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, the investigators have developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, the investigators aiming to brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients.
Twenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; subjects received the real tDCS+iTBS output) group or a sham NIBS (subjects received sham tDCS+iTBS output) group. All subjects underwent 1 h treatment of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
24
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Taipei city, Taiwan
- Taipei Medical University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
20 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Adequate understanding of verbal/written information and physically able to complete the motor learning of functional tasks with the affected hand.
Exclusion Criteria:
- Extremely sensitive to electrical stimulation and cannot tolerate it.
- Contracture on upper extremities, and limitation in joint range of motion.
- The muscle tone was severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of cardiopulmonary disease or arrhythmia.
- With implantable medical electronic devices, like pacemaker.
- Pressure sores or wounds on the skin of head and upper extremities.
- Metal implants in the head (neck).
- Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
- A history of seizure or other brain pathology.
- Brain surgery or severe brain trauma.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: tCES & upper extremity rehabilitation
The experiment group will receive tCES combined with upper extremity rehabilitation of affected side.
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The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms.
tCES will be applied for 20 minutes at an intensity of 1.0 -1.5 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 6 weeks.
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Comparatore fittizio: Sham tCES & upper extremity rehabilitation
The sham control group will receive sham tCES combined with upper extremity rehabilitation of affected side.
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The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms.
Sham tCES will consist of a 5-second ramp up to 1.0-1.5 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
Lasso di tempo: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The FMA-UE was performed (score ranges from 0 to 66) to assess upper limb motor recovery.
Each movement is estimated by a 3-point scale (0-1-2).
The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
Lasso di tempo: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The JTT assesses hand functions commonly used in activities of daily living.
The subtests are scored according to time taken to complete the task.
Total score is the sum of time taken for each subtest, with shorter times indicating better performance.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Change from baseline in the Finger to Nose Test after intervention
Lasso di tempo: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The Finger to Nose Test assesses coordination of upper-extremity movement.
The number of complete nose-target movements during a 1 min period will be recorded.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Modified Ashworth scale (MAS) measures
Lasso di tempo: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Chi-Wei Peng, Ph.D., School of Biomedical Engineering, Taipei Medical University
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 marzo 2017
Completamento primario (Effettivo)
31 gennaio 2020
Completamento dello studio (Effettivo)
30 aprile 2020
Date di iscrizione allo studio
Primo inviato
27 aprile 2020
Primo inviato che soddisfa i criteri di controllo qualità
27 aprile 2020
Primo Inserito (Effettivo)
30 aprile 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 aprile 2021
Ultimo verificato
1 aprile 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- N201702070
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .